A Study of Active Immunotherapy With GRNVAC1 in Patients With Acute Myelogenous Leukemia (AML)
A Phase II Study of Active Immunotherapy With GRNVAC1, Autologous Mature Dendritic Cells Transfected With mRNA Encoding Human Telomerase Reverse Transcriptase, in Patients With Acute Myelogenous Leukemia in Complete Clinical Remission
1 other identifier
interventional
21
1 country
6
Brief Summary
This is a phase II study to evaluate the safety, feasibility and efficacy of immunotherapy with GRNVAC1 in patients with AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2007
Longer than P75 for phase_2
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
July 30, 2007
CompletedFirst Posted
Study publicly available on registry
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJuly 9, 2019
July 1, 2019
4.4 years
July 30, 2007
July 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility will be assessed by examining whether enough cells are collected during leukapheresis, whether enough vaccine is manufactured for at least 2 injections, and whether the patient is still in remission when the vaccine is released.
1 year
Secondary Outcomes (1)
Immunological response, defined as the proportion of patients with a positive induction of hTERT-specific T cells to twice the pre-vaccination level, the proportion of patients with DTH, and event-free survival.
2 years
Study Arms (1)
GRNVAC1
EXPERIMENTALAutologous dendritic cell vaccine
Interventions
Eligibility Criteria
You may qualify if:
- AML in first complete remission (CR1) or in second complete remission (CR2) with CR1 \>/= 6 months
- Has completed at least one cycle of consolidation chemotherapy within past 6 months
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Adequate hepatic/renal function
You may not qualify if:
- CR1 and good risk cytogenetic features \[t(15;17), t(8;21), inv(16) or t(16:16)\]
- Central nervous system or leptomeningeal disease
- Allogeneic stem cell transplant planned or expected
- Documented allergy to penicillin or beta-lactam antibiotics
- Active or ongoing autoimmune disease
- Clinically significant pulmonary or cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Emory University School of Medicine
Atlanta, Georgia, 30322, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Washington University School of Medicine, Siteman Cancer Center
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Ohio State University
Columbus, Ohio, 43210, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John F DiPersio, MD,PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2007
First Posted
August 1, 2007
Study Start
July 1, 2007
Primary Completion
December 1, 2011
Study Completion
August 1, 2014
Last Updated
July 9, 2019
Record last verified: 2019-07